Spanish Decision Tool for Ovarian Cancer Maintenance Therapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Shared Medical Decision Tool, Engaging Patients in Decision Making, Literacy Spanish Language.
- Who it may be relevant to
- Registry conditions: Ovarian Cancer. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
Engaging Patients in Decision Making: The Development and Pilot Testing of a Low Literacy Spanish Language Shared Medical Decision Tool for Ovarian Cancer Maintenance Therapy
Overview
To develop a shared decision-making (SDM) tool to help Spanish-speaking patients make decisions about their maintenance therapy
Detailed description
Objectives:
* Create a low literacy version of a shared decision-making (SDM) tool for ovarian cancer maintenance therapy for Spanish speaking individuals. * To explore the feasibility and acceptability of incorporating the SDM tool into routine clinical care for Spanish speaking individuals. * To estimate the effectiveness of the SDM tool on quality of the decision making in patients with ovarian cancer who are making decisions about maintenance therapy through a pilot study.
Interventions
- Other Shared Medical Decision Tool
standard of care - Behavioral Engaging Patients in Decision Making
standard of care - Behavioral Literacy Spanish Language
standard of care
Primary outcome measures
- Decision Regret Scale questionnaire [Time frame: through study completion; an average of 2 year.]
Eligibility criteria
Study population: This study will enroll patients and clinical providers.
Inclusion criteria: Patients
- Eligible patients must be: 1) individuals ≥ 18 years with advanced stage high grade epithelial ovarian, fallopian tube or primary peritoneal cancer who are receiving or have completed platinum-based chemotherapy for ovarian cancer and are potentially eligible to receive maintenance therapy; 2) able to understand, speak or read in Spanish.
Exclusion criteria: Patients
- Inability or unwillingness to sign informed consent
Inclusion criteria: Clinicians
- Eligible clinicians will include: 1) MD Anderson gynecologic oncologists and advanced practice providers who practice at the Houston Area Locations (HALs), MD Anderson Cancer Center, or our county safety net hospital, The Harris Health System (LBJ Hospital).
Exclusion criteria: Clinicians
- Inability or unwillingness to sign informed consent
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Non-randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
United States · 1 center
- M D Anderson Cancer Center — Houston
Identifiers
NCT: NCT06036810 · 2022-0539 · NCI-2023-07034